ANTARA Patient Information

ANTARA and Your Diet:
Speak to your doctor about a cholesterol-lowering diet prior to being prescribed ANTARA® (fenofibrate capsules) 130 mg. You should continue this diet during treatment with ANTARA. ANTARA can be taken without regard to meals.
ANTARA and Dosing:
Because your kidneys are your body’s main way of removing ANTARA from your system, if you have reduced kidney function, you should be started on a treatment dose of 43 mg/day. If you are elderly, you should also be started on a dose of 43 mg/day. Speak to your doctor about your health and dosing amounts that are right for you.
Who Should Not Take ANTARA?
ANTARA, as with any fenofibrate, should not be used by people who are sensitive to a fenofibrate. As with any fenofibrate, ANTARA should not be used by people with liver problems, gallbladder problems, or severe kidney disease.
Fenofibrates and Checking Your Liver Function:
Fenofibrates may be associated with increasing certain liver enzymes found in the blood. These enzymes are called serum transaminases. Your doctor should monitor your liver function regularly. If your levels continue to be 3 times higher than the normal limit, your cholesterol-lowering treatment with ANTARA should be stopped. Ask your doctor about your liver function and at what intervals you should have it checked.
Fenofibrates in combination with a Statin Medication:
Taking ANTARA, as with any fenofibrate, while also taking a statin medication (HMG-CoA reductase inhibitor) should be avoided unless you and your doctor decide the benefits outweigh the risks. There have been reports of skeletal muscle disease (rhabdomyolysis), muscle contraction problems (resulting from increased creatine kinase levels), and muscle protein being excreted in urine (myoglobinuria). Speak to your doctor if you are taking a statin. Using a fibrate alone, even without a statin, may also occasionally result in muscle inflammation (myositis) and skeletal muscle disorders (myopathy, rhabdomyolysis). If you experience any type of muscle pain, tenderness, or weakness, contact your doctor immediately.
Fenofibrates and Gallstones:
In some instances, fenofibrates may lead to gallstones (cholelithiasis). Use of ANTARA may increase the effects of blood thinners, such as Coumadin® (warfarin sodium). Please inform your doctor if you are currently taking a blood thinner. Patients should be aware that inflammation of the pancreas, blood-related complications, and reactions based on a possible sensitivity to fenofibrates may occur. Ask your doctor about these possible effects, what you should look for, and what you should do if you become aware of them. Your doctor may adjust your dosage of ANTARA or may even discontinue its use if any of these events occur.
ANTARA and Pregnancy:
There are no adequate nor well-controlled studies of ANTARA in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Inform your doctor if you are pregnant or are considering getting pregnant while on a course of treatment with ANTARA.
ANTARA and Heart Disease:
The effect of ANTARA on heart disease and the sickness or death resulting from heart disease has not been evaluated.
ANTARA and Other Possible Drug Interactions:
To avoid a drug interaction, patients should take ANTARA at least 1 hour before or 4 to 6 hours after a bile acid binding resin.
Other Precautions and the Prescribing Information:
Other precautions include pancreatitis, hypersensitivity reactions, and blood changes. Please see Full Prescribing Information for a complete list of precautions.

Coumadin® (warfarin sodium) is a registered trademark of Bristol-Myers Squibb.

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Important Safety Information

ANTARA® (fenofibrate) capsules is contraindicated in patients with hypersensitivity to fenofibrate, in patients with hepatic or severe renal dysfunction including primary biliary cirrhosis, in patients with unexplained persistent liver function abnormality, and in patients with preexisting gallbladder disease.
Fenofibrate has been associated with increases in serum transaminases. Regular periodic monitoring of liver function should be performed, for duration of therapy, and therapy discontinued if enzyme levels persist above 3 times the normal limit.
There are no adequate and well-controlled studies in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (eg, >2000 mg/dL) may increase the risk of developing pancreatitis. ANTARA therapy on reducing this risk has not been studied.
Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, ANTARA therapy should be discontinued.
The combined use of ANTARA and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk. The combined use of fibric acid derivatives and HMG-CoA reductase inhibitors has been associated with rhabdomyolysis, markedly elevated creatine kinase levels, and myoglobinuria, leading to acute renal failure.
The use of fibrates alone including ANTARA, may occasionally be associated with myositis, myopathy, or rhabdomyolysis. Patients complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myopathy. Discontinue ANTARA if myopathy or myositis is suspected or diagnosed.
The effect of ANTARA on coronary heart disease morbidity and mortality and noncardiovascular mortality has not been established.
Patients treated with other fibrate drugs experienced an increase in noncardiovascular and cardiovascular morbidity and mortality compared with placebo-treated patients.
Other precautions include pancreatitis, hypersensitivity reactions, and hematologic changes. Refer to full Prescribing Information for a complete list of precautions.
Caution should be exercised when coumarin anticoagulants are given in conjunction with ANTARA. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized.
Since bile acid sequestrants may bind other drugs given concurrently, patients should take ANTARA at least 1 hour before or 4–6 hours after a bile acid binding resin to avoid impeding its absorption.
Cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine. Because renal excretion is the primary elimination route of fibrate drugs including ANTARA, there is a risk that an interaction will lead to deterioration. The benefits and risks of using ANTARA with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and lowest effective dose employed.
Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.
The most common (≥2% reported in clinical trials) side effects are: abnormal liver function test, including increased AST; increased ALT; CPK increase; respiratory disorder; abdominal pain; back pain; headache; diarrhea; nausea; rhinitis; asthenia; flu syndrome and constipation.

Please see full Prescribing Information.

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ANTARA Patient Information

ANTARA and Your Diet:

ANTARA and Dosing:

Who Should Not Take ANTARA?

Fenofibrates and Checking Your Liver Function:

Fenofibrates in combination with a Statin Medication:

Fenofibrates and Gallstones:

ANTARA and Pregnancy:

ANTARA and Heart Disease:

ANTARA and Other Possible Drug Interactions:

Other Precautions and the Prescribing Information: